Targeted Adherence Intervention to Reach Glycemic Control With Insulin Therapy for Patients With Diabetes

In an era of rapidly growing healthcare costs, due to in large part to the increasing burden
and complexity of chronic disease management, targeting outreach to patients who are most
likely to benefit from them and tailoring interventions to individual patient needs,
represent important opportunities to maximize healthcare value. The Targeted Adherence
intervention to Reach Glycemic control with Insulin Therapy for patients with Diabetes
(TARGIT-DM) trial is a pragmatic, intention-to-treat, randomized-controlled study that will
evaluate the impact of three equivalently-priced strategies to improve insulin persistence
and glycosylated hemoglobin [HbA1c] control among patients with diabetes on insulin.

The interventions in each of the three study arms will consist of educational mailings and
telephonic pharmacist outreach. The pharmacists will assess and address potential barriers to
insulin adherence and optimal glycemic control. The three study arms will employ differ both
in regards to which patients are targeted and the intensity of the engagement strategy used.
The low intensity intervention in arm 1 will be deployed to all subjects randomized to that
arm. The moderate and high intensity interventions will be delivered to focused populations
within arms 2 and 3, respectively, as defined by poor disease control and/or predicted risk
of non-adherence. The interventions provided in the moderate and high intensity arms will
also include feedback to the patient's provider, as needed, and potential enrollment in a
text messaging program. Patients in these two arms who are not targeted will receive usual
care.

The study population for this trial will consist of members enrolled in commercial insurance
provided by Horizon Blue Cross Blue Shield of New Jersey. Insurance claims data will be used
to apply the inclusion and exclusion criteria. Eligible patients will be randomized into one
of three arms, stratified by baseline availability of HbA1c and a valid telephone number.

Inclusion Criteria:

- Commercially-insured individuals receiving medical and pharmacy health insurance
benefits from Horizon Blue Cross Blue Shield of New Jersey

- At least 3 months of continuous enrollment prior to randomization

- At least 1 prescription for basal insulin, 6 months prior to randomization

- Type 2 diabetes diagnosis

Exclusion Criteria:

- Patients with Medicaid or Medicare as primary insurance